drugset / Trial / NCT06704100

Oral Fosamprenavir for GERD

NCT06704100 ↗

Phase 2 Not yet recruiting 60 enrolled Medical College of Wisconsin
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to learn if study drug Fosamprenavir administered orally improves symptoms for Proton Pump Inhibitor (PPI)-refractory Gastro Esophageal Reflux Disease (GERD). The main questions it aims to answer are: 1. Does fosamprenavir significantly improve heartburn severity over the 8-week treatment period 2. Does fosamprenavir significantly improve regurgitation frequency over the 8-week treatment period 3. Does fosamprenavir significantly improve symptoms of persistent GERD over the 8-week treatment period Researchers will compare fosamprenavir to a placebo (a look-alike substance that contains no active drug) to see if fosamprenavir works to treat PPI-refractory GERD. Participants will: 1. Take fosamprenavir or placebo every day BID (twice a day) for 8 weeks 2. Visit the Adult Translational Research Unit (ATRU) seven times for consenting, screening, and checkups and tests 3. Keep a daily diary of their symptoms of persistent GERD

Timeline

Start
2027-10-01
Primary completion
2028-12-31
Completion
2029-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fosamprenavir Small molecule 1400 mg Oral